(252 days)
No
The summary describes a standard dental implant system and its mechanical performance testing, with no mention of AI or ML capabilities.
No.
The device is a dental implant system intended to support prosthetic devices and restore chewing function, which is a structural and functional restoration, not a therapeutic treatment for a disease or condition.
No
The device is a dental implant system designed to support prosthetic devices and restore chewing function, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Dental Implants System" consisting of "Endosseous form dental implants" and "prosthetic abutments," which are physical hardware components. The performance studies also describe physical testing of these components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant placed in the body to support prosthetic devices and restore chewing function. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details the physical components of the dental implant system, which are surgically implanted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant system does not fit that description.
N/A
Intended Use / Indications for Use
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandbular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Alpha Dent Implants Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (regular/narrow/ wide/shoulder/esthetic abutment); Screw retained restorations: Multi unit, Titanium Esthetic abutments; Removable restorations: Ball attachments, Locators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or the mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical testing: Biocompatibility, Sterilization, Pyrogenicity, Accelerated aging, Static and dynamic compression performance test.
Sample Size: Not explicitly stated.
AUC: Not applicable.
MRMC: Not applicable.
Standalone Performance: Not explicitly stated as standalone performance, but test results demonstrated:
- SAL of 10-6 was achieved.
- All biological endpoints were met.
- The device meets pyrogen limit specifications.
- 5 years shelf life substantiated.
- Alpha Dent implants performed as good as the predicate-Neobiotech, with similar measured fatigue limits and run-out bending moment.
- Moist heat Sterilization for Abutments was validated and able to reduce 6 magnitudes of the biological indicator Geobacillus stearothermophilus based on the "full cycle" approach.
Key Results: "The results of the testing indicate that the Alpha Dent Implants System is substantial equivalent to the predicate devices sighted in this submission."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K181138 - IS-III active System, Neobiotech Co., Ltd
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K180968 – Alpha Dent Implants Ltd ; K181381-A.B. Dental Devices Ltd
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alpha Dent Implants GmbH Simha Sibony Regulatory Affairs Consultant Hanauer Street 8 Pforzheim, 75181 GERMANY
November 1, 2021
Re: K210499
Trade/Device Name: Alpha Dent Implants Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 20, 2021 Received: September 27, 2021
Dear Simha Sibony:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210449
Device Name Alpha Dent Implants Dental Implants System
Indications for Use (Describe)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandbular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small German flag.
510(k) Summary
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Alpha Dent Implants Dental Implants System
1. GENERAL INFORMATION
| Date Prepared: | October 18th, 2021 |
|---|---|
| Common Name: | Alpha Dent Implants Dental Implants System |
| Classification Name: | Implant, Endosseous, Root-Form |
| Class: | II |
| Product Code: | DZE |
| Subsequent product code | NHA |
| CFR section: | 21 CFR872.3640 |
| Device panel: | Dental |
| Legally Marketed Primary | |
| Predicate Device: | K181138 - IS-III active System, Neobiotech Co., Ltd |
| Legally Marketed | |
| Reference Devices: | K180968 – Alpha Dent Implants Ltd ; K181381-A.B. Dental Devices Ltd |
| Submitter: | Dr Boris Simanovski -CEO |
| Alpha Dent Implants GmbH | |
| Hanauer Str.8, 75181 Pforzheim, Germany | |
| E: dr.simanovski@gmail.com | |
| Tel: +4917678531156 | |
| Contact: | Simha Sibony- Regulatory Affairs Consultant |
| GMRE Ltd | |
| 21 Hazamir St. | |
| Nahariya 2226024 | |
| Israel | |
| Email: simhasibony@gmail.com | |
| Tel: +972-52-654-6625 |
2. DEVICE DESCRIPTION
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
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Image /page/4/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
IMPLANTS 2.1
IMPLANT ACTIVE KONUS 2.1.1
Alpha Dent Active Konus are implants with tapered external conical shape that mimics the shape of the natural tooth root. These implants are used at two stage protocol for all types of bones. Alpha Dent Active Konus are spiral, conic, with deep and sharp double threads for self- retention.
Active Konus implant has a platform with an inner cone and a hexagon for positioning. This type of platform allows creating a conical connection with suprastructures.
Narrow Platform 2,1 mm
| IAK- Implant Active Konus | Predicate K181138 |
|---|---|
| Length 8, 10, 11.5, 13 mm Diameter 3.3 mm | |
| Length 8, 10, 11.5,13 mm Diameter 3.75 mm | |
| Length 8, 10, 11.5,13 mm Diameter 4.2 mm | |
| Length 8, 10, 11.5,13 mm Diameter 5.0 mm | |
| Length 8, 10, 11.5,13 mm Diameter 6.0 mm | |
| Made of titanium alloy Ti 6Al 4V ELI |
2.1.2 IMPLANT CLASSIC KONUS
Classic Konus implant has a platform with an inner cone and a hexagon for the positioning of dental structures. This type of platform allows creating a conical connection with suprastructures. The 3.3 mm diameter implants are installed in front and lateral parts (canine teeth, incisors, premolar teeth).
Narrow Platform 2.1 mm
| ICK- Implant Classic Konus | Predicate K181138 |
|---|---|
| Length 10, 11.5, 13 mm Diameter 3.3 mm | |
| Length 8, 10, 11.5, 13 mm Diameter 3.75 mm | |
| Length 8, 10, 11.5, 13 mm Diameter 4.2, mm | |
| Length 8, 10, 11.5,13 mm Diameter 5.0 mm | |
| Length 8, 10, 11.5,13 mm Diameter 6.0 mm | |
| Made of titanium alloy Ti 6Al 4V ELI |
2.1.3 IMPLANT ACTIVE BIO
Active Bio is a conical-shaped implant with a helical thread. It is used under one- or two-steps procedure in all bone types.
Narrow Platform 2,1 mm
| IAB - Implant Active Bio | Predicate K181138 | |
|---|---|---|
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Image /page/5/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
Image /page/5/Picture/1 description: The image shows a close-up of a dental implant. The implant is made of metal and has a screw-like shape. The threads of the screw are visible, and there are also some holes in the implant. The implant is designed to be inserted into the jawbone to support a false tooth.
Length 8, 10, 11.5,13 mm Diameter 3.3 mm Length 8, 10, 11.5, 13 mm Diameter 3.75 mm Length 8, 10, 11.5, 13 mm Diameter 4.2, mm Length 8, 10, 11.5, 13 mm Diameter 5.0 mm Length 8, 10, 11.5, 13 mm Diameter 6.0 mm Made of titanium alloy Ti 6Al 4V ELI
2.2 PROSTHETIC COMPONENTS
The Alpha Dent Implants Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (regular/narrow/ wide/shoulder/esthetic abutment); Screw retained restorations: Multi unit, Titanium Esthetic abutments; Removable restorations: Ball attachments, Locators.
For all the prosthetic components of the subject device described below, the Implant – abutment connection is same platform with an inner cone and a hexagon for positioning:
NARROW CONICAL PLATFORM 2.1 mm (3.0)
This implant/abutment connection is compatible to all subject device implants: ICK, IAK, IAB
Straight Abutments- cemented retained reconstruction
A variety of titanium straight abutments are available for use in different cases. They are used in the fabrication of cement-retained restorations, single crowns or bridges.
Standard abutments with an extended body are used for thick gums, or when the implant is very deep.
- . Narrow abutments are used in minimal prosthetic space
- . Wide abutments are used in wide prosthetic spaces, mainly for posterior teeth.
● Anatomic abutments have a shape that is contoured to the gingiva to allow for individualization of a prosthetic unit.
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Image /page/6/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
| Image: Abutment 1 | STRAIGHT
CONICAL | Straight titanium
antirotational conical
abutment. Abutment
includes a screw.
Available in sizes: 7
mm, 9 mm, 11 and 12
mm. | |
|------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: Abutment 2 | STRAIGHT
CONICAL | Wide antirotational
titanium conical
abutment with hexagon.
Mainly used in the area
of posterior teeth. | |
| Image: Abutment 3 | STRAIGHT
CONICAL | Anatomical titanium
shoulder abutment
straight conical. | |
| Image: Abutment 4 | STRAIGHT
CONICAL | Anatomical titanium
shoulder wide abutment
straight conical.
Available in three
shoulder sizes: 1, 2, 3
mm. | |
| TAK3 – Titanium
Abutment Konus | | | |
| TAWK 3/9 -
Titanium Abutmet
Wide Konus | | | |
| TAK3001/002/003;
Anatomical
Titanium Shoulder
Abutment | | | |
| TAWK3001/002/003
– Anatomical
Titanium Shoulder
Wide Abutment | | | |
| | TAAK3/015 | 15°,
CONICAL | Angular antirotational
titanium conical
abutment 15° without a
shoulder.
It is used in cases, when
the implant is installed
at an angle. |
| Image: abutment | | | |
Angular Abutments - cemented retained reconstruction
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Image /page/7/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the company name, the word "IMPLANTS" is written in a smaller font. To the right of the word "IMPLANTS" is a small graphic of the German flag.
Angular abutments are used when a change to the axis of the implant is required. Normally used for constructing cement-retained single crowns or bridges. The abutments are available with angles of 15° and 25°.
- Angular, narrow abutments are used in minimal prosthetic space.
- . Angular anatomic abutments have a shape that is contoured to the gingiva. This enables an customization of the prosthetic unit. • Narrow top angular abutment allows minimal technical preparation
Titanium Angulated Abutments (shoulder)
| Image: dental abutment | | | Angular anatomical
titanium conical
abutment 15°and 15°
with shoulder 1-3 mm. |
|------------------------|-----------------|-----------------|-------------------------------------------------------------------------------------------------------------------|
| | TAAK3/01501/02/ | 15°,
CONICAL | It is used for aesthetic
tasks solving in
vestibular area, and
replicating the shape of
gingival line |
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Image /page/8/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small German flag.
| Image: Dental abutment | TAAK3/025
TAAK3/02502 | 25°, CONICAL | Angular anatomical titanium conical abutment 25° and 25° with shoulder 2 mm.
It is used for aesthetic tasks solving in vestibular area, and replicating the shape of gingival line. |
| ------------------------ | -------------------------- | -------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Ball attachment - removable prosthesis
The ball attachment prosthetic is intended to secure a removable prosthesis. The attachment is used in conjunction with a stainless-steel cap and an intermediate silicone insert. Not used for single unit reconstruction
| Image: Dental implant | BAK- Ball Attachment Konus
Length; 2, 3,4,5,6mm
Platform :
NARROW CONICAL PLATFORM 2.1 mm (3.0)Made of titanium alloy Ti 6Al 4V ELI | A structure with conical ball
attachment is used for
fixation of removable
denture. A cap made of
stainless
steel can be included, as well
as an intermediate silicone
cap of three different
degrees of hardness: soft,
standard,
and strong. |
| ----------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Locators with a conical connection is used for removable denture fixation.
| Image: dental implant | LCK3- Locators
Length; 2, 3,4,5,6 mm
Platform :
• NARROW CONICAL PLATFORM 2.1 mm (3.0)
Made of titanium alloy Ti 6Al 4V ELI | Locator with a conical
connection is used for
removable denture fixation.
A cap made of stainless steel
can be included, as well as an
intermediate silicone cap. |
| ----------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2.3 AESTHETIC ANTIROTATIONAL ABUTMENT (STRAIGHT MULTI-UNIT)
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Image /page/9/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
Aesthetic antirotational abutment (straight multi-unit) with a sleeve is used in order to restore a bridge with a screw retention.
Screw in with a maximum force of 20 newton
Image /page/9/Picture/3 description: The image shows an AEAK3 - Aesthetic Antirotational Abutment. The abutment has lengths of 1, 2, and 3 mm. The platform is a NARROW CONICAL PLATFORM with a size of 2.1 mm (3.0). The image shows a side view of the abutment.
AESTHETIC ABUTMENT (STRAIGHT MULTI-UNIT) 2.4
Aesthetic abutment (straight multi-unit) with a sleeve is used in order to restore a bridge with a screw retention.
Screw in with a maximum force of 20 newton
All aesthetic abutments are intended only for Multi Unit loaded restoration.
No single unit implant use with aesthetic abutments.
Image /page/9/Picture/9 description: The image shows a 3D rendering of a dental implant. The implant has a screw-like structure at the bottom, a cylindrical body in the middle, and a hexagonal head at the top. The implant is silver in color and appears to be made of metal.
- AEAK+ Aesthetic Abutment Length: 1, 2, 3 mm Platform : ● NARROW CONICAL PLATFORM 2.1 mm (3.0)
2.5 ONE-PIECE ANGULAR MULTI-UNIT 17° /30° CONICAL
Multi-unit system is used for a prosthesis with screw retention.
One-piece angular multi-unit allows rehabilitation at non-parallel implants by correcting the angle.
| 17°/30°Conical | |
|---|---|
| Image: Dental implant | MUBK3.0 – One Piece Angular Multi-Unit 17°/30° Conical |
| Length:1, 2, 3 mm | |
| Platform : | |
| • NARROW CONICAL PLATFORM 2.1 mm (3.0) |
- 2.6 HEALING CAP KONUS 3
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Image /page/10/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
The titanium conical healing cap is installed on the implant and is designed to form the gingival margin and gingival papilla. Available in the following heights: 2, 3, 4, 5, 7mm. The size is determined by the height of the gums.
Image /page/10/Picture/2 description: The image shows a 3D rendering of a dental implant. The implant has a cylindrical head with a slightly rounded top and several horizontal grooves. Below the head, the implant tapers down to a narrower, threaded screw-like section, which is designed to be inserted into the jawbone.
Healing cap konus 3 (HCK3) Length: 2, 3, 4, 5, 7 mm
HEALING CAP WIDE KONUS 3 2.7
Image /page/10/Picture/5 description: The image shows a close-up of a metal screw with a large, flat head. The screw has a cylindrical body with threads that run along its length. The head of the screw is wider than the body and has a smooth, rounded surface. The screw appears to be made of a shiny metal, possibly stainless steel or aluminum. The image is well-lit, and the screw is in focus.
Healing cap wide konus 3 (HCWK3) Length: 2, 3, 4, 5 mm
3. MATERIALS:
The implants are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications.
4. INDICATION FOR USE
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when primary stability is achieved and with appropriate occlusal loading.
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Image /page/11/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES Alpha Dent Implants Dental
Implants System subject to this submission is substantially equivalent to K181138 - IS-III active System, Neobiotech Co., Ltd in terms of intended use, implant/abutment connection design, materials used, safety and performance testing.
The surface treatment, packaging and sterilization are substantially equivalent to K180968 – Alpha Dent Dental Implants Ltd.
Evidence of equivalence has been demonstrated through:
- The Alpha Dent Implants Dental Implants System subject device's intended use and indications for use were previously cleared by FDA for the reference device K180968 – Alpha Dent Dental Implants Ltd.
-
- The technical characteristics of the Alpha Dent Implants System subject devices' are similar to those of reference device K180968 – Alpha Dent Dental Implants Ltd.
-
- Safety and performance testing of the Alpha Dent Implants System subject device's are similar to those of the predicate device K181138 - IS-III active System, Neobiotech Co.
Therefore, the Alpha Dent Implants Dental Implants System subject device is substantially equivalent to the predicate devices in terms of intended use, materials used, and technological characteristics.
| Device Name: | Implant IS-III active
Neobiotech
Primary Predicate | Implant
ALPHA DENT
Reference Predicate
Implant Active (IA)
ALPHA DENT
Reference Predicate | Implant Classic (IC)
ALPHA DENT
Reference Predicate | Implant Active Bio (IAB)
Implant Active Conus (IAK)
Implant Classic Conus (ICK)
ALPHA DENT |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510K Number | K181138 | K180968 | K180968 | Current Submission |
| Indications for use | [1] below this table | [2]below this table | [2]below this table | [2]below this table |
| Patient Population | Edentulous
or
partially | Edentulous
or
partially | Edentulous
or
partially | Edentulous
or
partially |
| | edentulous individuals | edentulous individuals | edentulous individuals | edentulous individuals |
| Material | TI CP4 of ASTM F67. | Ti Grade 5 (Ti6AL4V- | Ti Grade 5 (Ti6AL4V-ELI) | Ti Grade 5 (Ti6AL4V-ELI) |
| | | ELI) ASTM F136-13 | ASTM F136-13 | ASTM F136-13 |
| Outer Diameters
(mm) | 3.5; 4.0; 4.5; 5.0; 6.0; 7.0" | 3.3; 3.75; 4.2; 5.0 | 3.3; 3.75; 4.2; 5.0 | 3.3; 3.75; 4.2; 5.0; 6.0 |
| Length (mm) | 7.3;8.5; 10.0; 11.5; 13.0;
15.0" | 8.0; 10.0; 11.5; 13.0; 16.0 | 8.0; 10.0; 11.5; 13.0; 16.0 | 8.0; 10.0; 11.5; 13.0; 16.0 |
| Thread Design | Self-tapping | Self-tapping | Self-tapping | Self-tapping |
| Recommended
type of Bone | Bone - All Types | Soft Bone
(Type 3-4) | Hard Bone
(Type 1-2) | Bone - All Types |
| Implant/abutment
connection | Internal Hexagon for anti-
rotation and Internal Cone | Internal Hex Connection
2.4mm | Internal Hex Connection
2.4mm | Internal Hexagon for anti-
rotation and Internal Cone |
| Placement in Bone | Bone Level | Bone Level | Bone Level | Bone Level |
| Surface
treatments | SLA | Anodized layer | Anodized layer | Anodized layer |
| Clinical procedure | This product is a root type
fixture which is inserted in
the alveolar bone. It
replaces the functions of
the missing teeth as a
dental implant fixture. | Immediate loading or for
loading after a
conventional healing
period | Immediate loading or for
loading after a
conventional healing
period | Immediate loading or for
loading after a
conventional healing
period |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
Table 1: Implants Comparison Table
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Image /page/12/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
[1] The IS-III Active Fixture is intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the wing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[2] Alpha Dent Implants Dental Intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single teeth applications. The prostheses can be screw or cement. The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Table 2: Implants' Prosthetics Comparison Table
| Device Name: | Healing caps for implants with internal hexagon connection
Manufacturer: AlphaDent | Healing caps for implants with conical connection.
Manufacturer: AlphaDent |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | HC:
Diameter: 4.5 mm
Length: 2,3,4,5 and 7 mm
Platform: 3.75 mm
HCW:
Diameter: 5.5 mm
Length: 2,3,4,5
Platform: 3.75 mm | HCK 3:
Diameter: 4.2 mm
Length: 2,3,4,5 and 7 mm
Platform: 2.80 mm
HCWK 3:
Diameter: 5.5 mm
Length: 2,3,4,5
Platform: 2.80 mm |
| Principle of Operation | This product is healing cap to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. | This product is healing cap to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. |
| Device Name: | Abutments for implants with internal hexagon connection
Manufacturer: AlphaDent | Abutments for implants with conical connection.
Manufacturer: AlphaDent |
| 510K Number | K180968 | Current submission |
| Connection | Internal Hexagon connection | Conical hexagon |
| Sterility: | Non-Sterile | Non-Sterile |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size/geometry | TA - Straight anti rotation abutment
TA-Standard:
Diameter: 4.5 mm;
Length: 7, 9, 12 mm
Platform: 3.75 mm
TA0XX - Titanium Abutment Shoulder
Diameter: 4.5 mm
Length: 1, 2, 3 mm
Platform: 3.75 mm
TAW-Straight anti rotation abutment
TAW-Wide:
Diameter: 5.5mm;
Length: 9, 12 mm
Platform: 3.75 mm
TA0XXW- Titanium Abutment Shoulder Wide
Diameter: 5.5 mm | TAK 3XX - Titanium Abutment Konus.
Diameter: 3.35 mm
Length: 7, 9, 12 mm
Platform: 2.80 mm
TAK 3/0XX - Titanium Abutment Konus Shoulder
Diameter: 4.2 mm
Length: 1, 2, 3 mm
Platform: 2.80 mm
TAWK 3/9 - Titanium Abutment Wide Konus
Diameter: 5.0 mm
Length: 9 mm
Platform: 2.80 mm
TAWK 3/0XX - Titanium Abutment Shoulder Wide Konus
Diameter: 5.5 mm
Shoulder: 1, 2, 3 mm |
| | TAA0XXYY - Titanium Angulated
Abutment-shoulder
Diameter: 4.5 mm
Shoulder: 1, 2 , 3 mm
Platform: 3.75 mm
Angle: 15 deg and 25 deg.
TAA - Angular Abutments
Diameter: 4.80 mm
Platform: 3.75 mm
Angle: 15 deg and 25 deg. | TAAK3/0XXYY - Angulated Titanium Abutment Konus
Diameter: 4.2 mm
Shoulder: 1, 2 , 3 mm
Platform: 2.80 mm
Angle: 15 deg and 25 deg.
TAAK3/0XX - Angulated Titanium Abutment Konus
Diameter: 3.35 mm
Platform: 2.80 mm
Angle: 15 deg and 25 deg. |
| Principle of Operation | It is indicated for screw retained single
tooth or cement retained single tooth
and bridge restorations. | It is indicated for screw retained single tooth or cement
retained single tooth and bridge restorations. |
| Device Name: | Ball Attachments for implants with
internal hexagon connection
Manufacturer: AlphaDent | Ball Attachments for implants with conical connection.
Manufacturer: AlphaDent |
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | BA- Ball attachment
Diameter: 4.0 mm
Heights: 1, 2, 3, 4, 5, 6 mm
Platform: 3.75 mm | BAK3 - Ball Attachment Konus
Diameter 4.2 mm
Heights: 2, 3, 4, 5, 6 mm
Platform: 2.80 mm |
| Principle of Operation | Used for implant retained mucosa-
supported restorations, such as
overdentures where the patient is fully | Used for implant retained mucosa-supported restorations,
such as overdentures where the patient is fully edentulous
in the arch to be restored. |
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Image /page/13/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and a small German flag is to the right of the word "IMPLANTS".
| | Antirotational Esthetic Abutment for implants
with internal hexagon connection
Manufacturer: AlphaDent | Antirotational Esthetic Abutment for implants
with conical connection.
Manufacturer: AlphaDent |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | AEA - Esthetic Antirotational
Diameter: 4.7 mm
Heights: 1, 2, 3 mm
Platform: 3.75 mm | AEAK - Antirotational Esthetic Abutment Konus
Diameter: 4.7 mm
Heights: 1, 2, 3 mm
Platform: 2.80 mm |
| Principle of Operation | Esthetic Screw Abutment is designed for the screw
retained rehabilitation process on single or
multiple units. | Esthetic Screw Abutment is designed for the screw
retained rehabilitation process on multiple units. |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface treatment, general shape (design) and dimensions. | |
| | Esthetic Abutment for implants with internal
hexagon connection
Manufacturer: AlphaDent | Esthetic Abutment for implants with conical
connection.
Manufacturer: AlphaDent |
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | TAE - Titanium Esthetic Abutments
Diameter: 4.3 mm
Heights: 1, 2, 3 mm
Platform: 3.75 mm | AEAK + - Esthetic Abutment Konus
Diameter: 4.3 mm
Heights: 1, 2, 3 mm
Platform: 2.80 mm |
| Principle of Operation | Esthetic Screw Abutment is designed for the screw
retained rehabilitation process on single or
multiple units. | Esthetic Screw Abutment is designed for the screw
retained rehabilitation process on multiple units. |
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Image /page/14/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small image of the German flag.
| One-Piece angular multi-unit for implants with | One-Piece angular multi-unit for implants with | |||
|---|---|---|---|---|
| Device Name: | internal hexagon connection | conical connection. | ||
| Manufacturer: AlphaDent | Manufacturer: AlphaDent | |||
| 510K Number | K180968 | Current submission | ||
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) | ||
| Size | MUB - Multi-Unit Base | MUBK3 – One-Piece angular multi-unit | ||
| Diameter: 4.3 mm | Diameter: 4.3 mm | |||
| Heights: 1, 2, 3 mm | Heights: 1, 2, 3 mm | |||
| Platform: 3.75 mm | Platform: 2.80 mm | |||
| Angle: 17 /30 deg | Angle: 17/30 deg. | |||
| Multi-unit Angled Base is a pre-manufactured | Multi-unit Angled Base is a pre-manufactured | |||
| Principle of Operation | prosthetic component directly connected to the | prosthetic component directly connected to the | ||
| Endosseous dental implant and is intended for use | Endosseous dental implant and is intended for use | |||
| as an aid in prosthetic rehabilitation. | as an aid in prosthetic rehabilitation. | |||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface treatment, | |||
| general shape (design) and dimensions. | ||||
| Locators for implants with internal hexagon | Locators for implants with conical connection. | |||
| Device Name: | connection | Manufacturer: AlphaDent | ||
| Manufacturer: A.B.Dental | ||||
| 510K Number | Current submission | |||
| K181381 | ||||
| Material | Grade 5 (Ti6AL4V-ELI) | |||
| Grade 5 (Ti6AL4V-ELI) | ||||
| Size | P25 - A.B. LOC Abutments | LCK3 — Locator | ||
| Diameter: 3.75 mm | Diameter: 3.75 mm | |||
| Head diameter: 3.85 mm | Head diameter: 3.85 mm | |||
| Heights: 0, 1, 2, 3, 4, 5, 6, 7 mm | Heights: 2, 3, 4, 5, 6 mm | |||
| Platform: 3.75 mm | Platform: 2.80 mm | |||
| Used for implant retained mucosa-supported | Used for implant retained mucosa-supported | |||
| restorations, such as overdentures where the | restorations, such as overdentures where the | |||
| Principle of Operation | patient is fully edentulous in the arch to be | patient is fully edentulous in the arch to be |
Similarities:
The subject device and primary predicate(K181138) have the same conical Hexagon Implant/abutment connection.
The subject device and reference predicate (K180968) have same indications for use, materials, surface treatment, general shape (design) and dimensions, function (implant/abutment range) and packaging (sterile barrier).
Differences: There is a slight difference in design and dimensions between primary predicate Neobiotech (K181138) and the subject device AlphaDent Konus.
The difference is in the implant/abutment connection
There is a minor difference in the type of internal thread M1.80-6H for the Neobiotech predicate device and 1-72 UNF 2B for Alpha Dent subject device. Both implants feature have identical thread outer diameter of 1.80 mm and therefore the thread type variation will not affect structural performance of the implant, furthermore both implants' threads offer same pitch design and therefore deemed equivalent.
6. NON-CLINICAL TEST
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Image /page/15/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and next to it is a small graphic that appears to be the German flag.
The Implants are packaged in clean room ISO CLASS 7 using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10° validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The components are manufactured from medical grade Titanium alloy (Ti 6Al 4V ELI) per ASTM F 136. Biocompatibility evaluation was conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and, FDA guidance Use of International Standard ISO 10993-
1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The biocompatibility evaluation established that all biological endpoints were met and that the device is biocompatible for its intended use.
SEM and Surface analysis (EDS) after Anodize process demonstrated the morphology and cleanliness of the final product.
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 in order to ensure safety and effectiveness related to Alpha Dent Implants Dental Implants System. Test results have demonstrated that the SAL of 106 was achieved and all testing requirements were met.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile." The method used to determine that the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on USP .
Accelerated aging per ASTM-F-1980 have been applied on the final packaging followed by validating package integrity in order to substantiate 5 years shelf life.
Real Time shelf life study is ongoing.
Static and dynamic compression performance test was conducted per ISO 14801- Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants.
The worst case scenario was chosen based on the FDA guideline for Endosseous, root-form implants. The implant used in the testing was the smallest in diameter and the longest in length available with this system of implants. The 25° abutment was chosen as worst case combination prosthetic component.
Alpha Dent implants that are subject to this submission have performed as good as the predicate-Neobiotech. The measured fatigue limits fall similar, compared to the Neobiotech, and the run-out bending moment in these tests was within similar values than predicate devices Neobiotech (metal dental implants with a diameter of 3.5 mm).
Therefore, we are confident that Alpha Dent Implants can rely on these results to define Substantial equivalence to predicate device.
Abutments are supplied Non sterile and are to be sterilized by end user by moist heat sterilization. Moist heat Sterilization for Abutments was validated in compliance with ANSI/AAMI/ISO 17665-1 and the test results demonstrated that the sterilization process for abutments as stated by Alpha Dent Implants, was able to reduce 6 magnitudes of the biological indicator Geobacillus stearothermophilus based on the "full cycle" approach.
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Image /page/16/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
The results of the testing indicate that the Alpha Dent Implants System is substantial equivalent to the predicate devices sighted in this submission.
CLINICAL TEST
No clinical studies were performed.
CONCLUSION
Based on the analysis of the comparison between the predicate device and the subject device and the performance evaluation results contained in this premarket notification, it was concluded that the proposed device is substantially equivalent to the legally marketed predicate devices (primary and reference devices). Testing data shows that the subject device does not present questions of safety or effectiveness that were not addressed by Alpha Dent Implants. Substantial equivalence to the predicate devices were established based on the existing performance tests provided in this 510(k) Submission. The Active Bio (IAB), Active Konus (IAK), Classic Konus (ICK) implants and the predicate Implant IS-III Active that was previously cleared under 510(k) number K181138 are both intended for the same use, and are operated using equivalent clinical procedures. The reference to the Classic(IC) and Active(IS)implants, cleared under K180968, was made in order to support the indications for use, materials, surface treatment, general shape (design) and dimensions, function(implant/abutment range),packaging (sterile barrier)and sterilization.